Label: GILTUSS CHILDRENS COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

  • NDC Code(s): 65852-011-04
  • Packager: Dextrum Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 17, 2025

If you are a consumer or patient please visit this version.

  • Drug Facts

    drugActive Ingredients ( in each 2.5 ml) Purposes

    Dextrometorphan HBr, 7.5 mg ----------------------Cough suppresant

    Guafenesin, 150 mg -----------------------------------Expectorant

    Phenylepryne HCL, 5 mg -----------------------------Nasal Decongestant

  • Use section

    usesUses * temporary relieves* cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants*

    the intensity of coughing**the impulse to cough to help your child get to sleep* helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes*temporary relieves nasal congestion due to a cold*stuffy nose

  • Warnings

    Donot use if your child is now taking a prescription monoamine oxidase inhibitor (MAOI) ( certain drugs for deppresion, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your's child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this oroduct.warnings

  • Ask a doctor

    Ask a doctorAsk a doctor before use if your child has *heart desease, high blood pressure, thryroid desease, diabetes* a cough with too much phlegm ( mucus)* a persistent or chronic cough as occurs with asthma or chronic bronchitis

    Ask a doctor or pharmacist before use if your child is taking any other nasal descongestant or stimulant, sedatives, tranquilizer, andndrugs used for depression, especially monoamine oxidase inhibitors (MAOIs)* When using this product do not use more than directed

    Stop use and ask a Doctor if * nervousness,dizziness or sleeplesness occur* sympton do not get better within 7 days or are accompanied by fever* cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent haedache . These could be signs of serious conditions.

  • PREGNANCY OR BREAST FEEDING

    If pregnantIf pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose , get medical or professional help or contact a Poisson Control Center inmediatly

  • Directions and other information

    Directions* no take more than 6 doses in any 24 hours period * use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter

    Children under 4 years ----Consult a doctor

    children 4 to under 6 years------1.25 ml every 4 hours

    children 6 to under 12 years-----2.5 ml every 4 hours

    children 12 yeras and over -------5 ml every 4 hours

    Other information

    store at room temperature 15 - 30 0c* close cap tightly* save carton for complete drug facts Directions

  • Questions section

    Call 1-787-848-9114, Monday-Friday 9AM-5PM EST

    Call your doctor for medical advice in the event of side efects Questions

  • Active ingredients section

    Active ingredients ( in each 2.5 ml)

    Dextrometorphan HBr, 7.5 mg

    Guaifenesin,150 mg

    Phenylephryne, 5 mg Active ingredients

  • Inactive Ingredients

    Inactive Ingredients

    Citric Acid, Flavor, Glycerin, Hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose

  • Keep out of reach of children

    Keep out of reach of children.

    In case of accidental overdose , get medical or professional help or contact a Poison Control Center inmediatly

    Keep out

  • Indication and Usage section

    Indication and Usage section

    no take more than 6 doses in any 24 hours period

    use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter

    Children under 4 years ----Consult a doctor

    children 4 to under 6 years------1.25 ml every 4 hours

    children 6 to under 12 years-----2.5 ml every 4 hours

    children 12 yeras and over -------5 ml every 4 hours

    indication an user

  • Purpose sectiion

    Purpose sectiion

    Cough Suppressant

    Expectorant

    Nasal descongestant

    purpose

  • Principal panel

    Childrens 4-12

    Cough & Cold

    Alcohol free

    Sugar free

    Dye free

    Non -Drowsy

    Cherry Flavor Principal panel

  • INGREDIENTS AND APPEARANCE
    GILTUSS CHILDRENS COUGH AND COLD 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65852-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 2.5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 2.5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN150 mg  in 2.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65852-011-041 in 1 CARTON11/07/2018
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/07/2018
    Labeler - Dextrum Laboratories Inc. (007392322)